DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The preliminary amendment filed 12/7/23 is acknowledged. Claims 1-25 have been canceled. Claims 26-49 have been added. Claims 26-49 are pending and under examination.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 26-49 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
The term “improving” in claim 26 is a relative term which renders the claim indefinite. The term “improving” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The specification does not define the phrase “improving an immunotherapy response” such that one of skill in the art would know what standard is used for making the determination that the response has been improved. Therefore, the claim scope is ambiguous and one of skill in the art would not be apprised of the metes and bounds of the claim. Dependent claims 27-49 do not cure the deficiency of claim 26, and thus, are included in the rejection.
Claim 47 recites the limitation "the cancer is melanoma" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 47 depends from claim 26, and there is no recitation of “a cancer” in the claim. Clarification and/or correction is required.
Claim 48 recites the limitation "the cancer is colon cancer" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 48 depends from claim 26, and there is no recitation of “a cancer” in the claim. Clarification and/or correction is required.
Claim 49 recites the limitation "the cancer is lung cancer" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 49 depends from claim 26, and there is no recitation of “a cancer” in the claim. Clarification and/or correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 26, 29-32, 35-38, 41-44, and 47-49 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Barreira da Silva et al. (Nature Immunology, published inline June 15, 2015; 16(8):850-860).
The instant claims are drawn to a method of improving an immunotherapy response in a patient, comprising administering a DPP4 inhibitor selected from Sitagliptin, Vildagliptin, Saxagliptin, Linagliptin, Anagliptin, Teneligliptin, Alogliptin, Gemigliptin, Dutogliptin, Trelagliptin, Dutogliptin, Omarigliptin, Berberine, Carmegliptin, Denagliptin, 2-[4-{{2-(2S,5R)-2-cyano-5-ethynyl-1-pyrrolidinyl]-2-oxoethyl]amino]- 4- methyl-1-piperidinyl]-4-pyridinecarboxylic acid, (4R, 5S)-5-amino-4-(2,4,5- trifluorophenyl) cyclohex-1-enyl)-(3-(trifluoromethyl)-5,6-dihydro- [1,2,4] triazolo [4,3- a]pyrazine-7(8H)-yl) methanone, and Lupeol to a patient receiving an immune checkpoint blockade molecule that is a monoclonal antibody that targets CTLA-4, PD-L1 or PD-1.
Barreira da Silva et al. teach a method of treating colorectal cancer comprising administering a DPP4 inhibitor (sitagliptin) in combination with an anti-PD-1 antibody and an anti-CTLA-4 antibody (See pages 856-857 and figure 7). Barreira da Silva et al. teach treating a solid tumor (B16F10 melanoma tumor and colorectal tumor) comprising administering a DPP4 inhibitor (sitagliptin) (See pages 851 and 856). Barreira da Silva et al. teach that administering DPP4 enhances infiltration into of the tumor by T lymphocytes (See page 853). Barreira da Silva et al. teach that the T lymphocytes express CXCR3 (See page 853). Barreira da Silva et al. teach that DPP4 inhibition significantly reduced the number of lung metastases in treated mice compared with control mice (See pages 851-852). Thus, Barreira da Silva et al. anticipate the claims. Thus, Barreira da Silva et al. anticipate the claims.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 26-46 and 49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karasik et al. (US Patent Application Publication 2011/0046071 A1, published February 24, 2001) in view of NCT02174172. Hoffmann-La Roche. A Study to Assess the Safety and Tolerability of Atezolizumab in Combination With Other Immune-Modulating Therapies in Participants With Locally Advanced or Metastatic Solid Tumors. Available from: https://clinicaltrials.gov/study/NCT02174172. NLM identifier. NCT 02174172. First posted June 24, 2014.
The instant claims are drawn to a method of improving an immunotherapy response in a patient, comprising administering a DPP4 inhibitor selected from Sitagliptin, Vildagliptin, Saxagliptin, Linagliptin, Anagliptin, Teneligliptin, Alogliptin, Gemigliptin, Dutogliptin, Trelagliptin, Dutogliptin, Omarigliptin, Berberine, Carmegliptin, Denagliptin, 2-[4-{{2-(2S,5R)-2-cyano-5-ethynyl-1-pyrrolidinyl]-2-oxoethyl]amino]- 4- methyl-1-piperidinyl]-4-pyridinecarboxylic acid, (4R, 5S)-5-amino-4-(2,4,5- trifluorophenyl) cyclohex-1-enyl)-(3-(trifluoromethyl)-5,6-dihydro- [1,2,4] triazolo [4,3- a]pyrazine-7(8H)-yl) methanone, and Lupeol to a patient receiving an immune checkpoint blockade molecule that is a monoclonal antibody that targets CTLA-4, PD-L1 or PD-1.
Karasik et al. teach a method of treating metastatic cancer comprising administering a DPP-IV inhibitor, wherein the DPP-IV inhibitor is selected from the group consisting of sitagliptin, Vildagliptin, saxagliptin, algoliptin, lingaliptin and Val-Pyr, derivatives thereof, analogs thereof, mimetics thereof, and salts thereof (See claims 51-55, and 62 and paragraph 0009, 0018, 0021, 0055-0059 and 0127). Karasik et al. teach that the cancer is metastatic lung cancer (See paragraph 0032 and claims 51-55). Karasik et al. teach that the DPP-IV inhibitor can be administered in a combination therapy (See paragraph 0024-0026).
Karasik et al. do not teach wherein the patient is receiving an immune checkpoint blockade molecule that is a monoclonal antibody that targets CTLA-4, PD-L1 or PD-1.
However, Clinical trial NCT02174172 teaches a method of treating advanced or metastatic malignancies comprising administering atezolizumab (also known as MPDL3280A) (See page 11). NCT02174172 teaches the patients have advanced or metastatic renal cell carcinoma, melanoma, or NSCLC (See pages 11 and 15-16). NCT02174172 teaches that some patients have previously received MPDL3280A as a monotherapy or in combination with other agents (See 16).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of treating metastatic cancer, as taught by Karasik et al., to include atezolizumab because NCT02174172 teaches that atezolizumab is effective for treating metastatic cancer. One of ordinary skill in the art would be motivated to do so because each of the therapies have been individually taught in the prior art to be successful for treating metastatic cancer. Moreover, the instant situation is amenable to the type of analysis set forth in In re Kerkhoven, 205 USPQ 1069 (CCPA 1980) wherein the court held that it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the very same purpose. The idea of combining them flows logically from having been individually taught in the prior art. Applying the same logic to the instant claims, one of ordinary skill in the art would have been imbued with at least a reasonable expectation of success that by administering a DPP-IV inhibitor in combination with atezolizumab as taught in Karasik et al. in view of the teachings of NCT02174172, one would achieve a composition for treating metastatic cancer. The use of the claimed DPP-IV inhibitors and in combination with atezolizumab to treat metastatic cancer is nothing “more than the predictable use of prior art elements according to their established functions.” KSR, 550 U.S. at 417.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses combining prior art elements according to known methods to yield predictable results, thus the combination is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that "The combination of familiar element according to known methods is likely to be obvious when it does no more than yield predictable results". The combination would have yielded a reasonable expectation of success along with predictable results to one of ordinary skill in the art at the time of the invention. Thus, it would have been obvious to a person of ordinary skill in the art to combine prior art elements according to known methods that is ready for improvement to yield predictable results. The claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 26-27 and 29-49 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11,000,521. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite the same DPPIV inhibitors (i.e., Sitagliptin, Linagliptin, and Alogliptin), and administering an anti-PD1 antibody (Nivolumab) or anti-CTLA4 antibody (Ipilimumab) for treating cancer. Although the instant claims are directed toward a method improving an immune response comprising administering the recited DPP4 inhibitors in combination with a subject receiving an anti-PD1 antibody (Nivolumab) or anti-CTLA4 antibody (Ipilimumab), the specification of the ‘521 patent clearly teaches that the composition comprising the DPP4 inhibitor and nivolumab or ipilimumab may be administered to a subject for treating cancer (see columns 2-3, 5, and 16-18 of the ‘521 Specification). In light of Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008) and especially in light of Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003) and Sun Pharmaceutical Industries v. Eli Lilly and Co., 611 F. 3d 1381, 1385 (CAFC 2010), a method improving an immune response comprising administering the recited DPP4 inhibitors in combination with a subject receiving an anti-PD1 antibody or anti-CTLA4 antibody is an obvious variation of the claims 1-4 of the ‘521 patent because one would readily understand that the composition of claim 1 of the ‘521 patent could be administered for treating cancer.
Please note that when considering whether the invention defined in a claim of an application would have been an obvious variation of the invention defined in the claim of a patent, the disclosure of the patent may not be used as prior art. General Foods Corp. v. Studiengesellschaft Kohle mbH, 972 F.2d 1272, 1279, 23 USPQ2d 1839, 1846 (Fed. Cir. 1992). However, this does not mean that one is precluded from all use of the patent disclosure. For example, the patent may be consulted in order to determine the utility of a claimed compound. See Sun Pharmaceutical Industries v. Eli Lilly and Co., 611 F. 3d 1381, 1385 (CAFC 2010) (“Our prior obviousness-type double patenting decisions in Geneva and Pfizer, which addressed factual situations closely resembling that presently before the court, control this case. In both cases, we found claims of a later patent invalid for obviousness-type double patenting where an earlier patent claimed a compound, disclosing its utility in the specification, and a later patent claimed a method of using the compound for a use described in the specification of the earlier patent”).
Claims 26-27, 29-46 and 48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11,229,645. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to improving an immune response in a subject in need thereof comprising administering sitagliptin and an immune checkpoint inhibitor targeting PD-1 and CTLA4. Both sets of claims recite that the subject has colon cancer. Thus, the instant claims and the ‘645 claims are of the same scope and are not patentably distinct.
Claims 26-27, 29-32, 35-38, 41-44, and 48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11,883,398. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to treating cancer in a subject in need thereof comprising administering a DPP4 inhibitor and an immune checkpoint inhibitor targeting PD-1 and CTLA4. Both sets of claims recite the DPP4 inhibitor is selected from the group consisting of a Dipeptidylpeptidase 4 (DPP4) inhibitor selected from Sitagliptin, Vildagliptin, Saxagliptin, Linagliptin, Anagliptin, Teneligliptin, Alogliptin, Gemigliptin, Dutogliptin, Trelagliptin, Omarigliptin, Carmegliptin, Denagliptin, 2-[4-{{2-(2S,5R)-2-cyano-5-ethynyl-1-pyrrolidinyl]-2-oxoethyl]amino]-4-methyl-1-piperidinyl]-4-pyridinecarboxylic acid, (4R, 5S)-5-amino-4-(2,4,5-trifluorophenyl) cyclohex-1-enyl)-(3-(trifluoromethyl)-5,6-dihydro-[1,2,4] triazolo [4,3-a]pyrazine-7(8H)-yl) methanone, or Lupeol. Both sets of claims recite that the subject has colon cancer. Thus, the instant claims and the ‘398 claims are of the same scope and are not patentably distinct.
Claim Status
No claims are allowed.
Conclusion
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/SANDRA CARTER/Examiner, Art Unit 1674
/VANESSA L. FORD/Supervisory Patent Examiner, Art Unit 1674
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